St Petersburg Dermatology

Summary Statement of Deficiencies D0000 An on-site announced CLIA recertification survey was conducted at St. Petersburg Dermatology on 06/05/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Nursing Manager, the laboratory failed to ensure 5 of 5 bottles of Mineral Oil and 4 of 4 bottles of Chlorazol Black were properly labeled with the name of the reagent, lot number, expiration date, and date in use. Findings included: During a tour of the laboratory on 06/05/2024 at 11:50 am, five bottles containing a clear liquid were observed. One bottle was labeled "Mineral", one had a blank label, and three contained no labels. Four bottles containing a dark liquid were also observed. Two of the bottles were labeled "KOH", one was labeled "Chlorazol Black E KOH", and one contained no label. During the observation on 06/05/2024 at 11:50 a.m., the Nursing Manager confirmed the Mineral Oil used for Scabies testing and Chlorazol bottles used for Fungi testing were not labeled properly. Record review of the laboratory's policy titled Quality Assurance for Routine Stains showed "All reagents and supplies used in the lab will be documented upon opening and put in use. This will consist of open date, lot number, and expiration date." Photographic evidence was obtained. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Nursing Manager and Testing Personnel #C, the laboratory failed to ensure the Chlorazol Black that was used for mycology (Fungi) testing was not expired prior to performing seven patient tests from 08/18/23 to 03/06/24. Findings included: On 06/05/24 at 11:30 a.m., observation of the Chlorazol Black container revealed the Lot number was 1120 and the expiration date was 04/30/2023. A review of the patient testing log revealed seven patients were tested for Fungi using the expired solution (8/18/23, 11/29/23, 12/6/23, 12/12/23, 12/15/23, 02/07/24, and 03/06/2024). On 06/05/2024 at 11:30 AM, the Nursing Manager stated she had pulled the original container of Chlorazol Black from the shelf but not the aliquoted bottles in the examination rooms. On 06/05/2024 at 11: 55 AM, Testing Personnel #C stated he did not know that the aliquoted bottles of Chlorazol Black were expired. Photographic evidence was obtained. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at St. Petersburg Dermatology on 08/16/2022 - 08/30/2022. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Lab Manager the laboratory failed to perform competency evaluations on 4 out of 4 (#A, #B, #C, #D) Laboratory Personnel. Findings Included: Review of the laboratory's policy and procedure titled "Competency and CLIA competency assessment" last signed by the Laboratory Director on 12/21/2018 revealed "Evaluation and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual sees patient specimens. After the first year, competency assessment must be performed at least annually." It also stated that "Documented competency is required for individuals Clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to comply with the procedures in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." Review of the CMS 209, Laboratory Personnel Report, signed by the Laboratory Director on 08/30/2022 revealed Laboratory Personnel #C acted as the Technical Supervisor for Histopathology and Testing Person for High Complexity, Laboratory Personnel #A and #D performed High Complexity testing, and Laboratory Personnel #B acted as the Technical Consultant and Testing Person for Moderate Complexity. Review of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Laboratory Personnel files revealed no evidence of completed competency evaluations. During an interview on 08/16/2022 at 2:00 PM, the Lab Manager confirmed that there were no completed competencies in the personnel files for Testing Personnel #A-#D. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Lab Manager the laboratory failed to verify the accuracy of Histopathology testing at least twice a year for 2 out of 2 years (2020-2022) reviewed. Findings Included: Review of Proficiency Testing revealed no proficiency or peer reviews for Histopathology testing for 2020, 2021, or 2022. On 08 /16/2022 at 3:30 PM, the Lab Manager confirmed that the documentation to confirm that this was done could not be located. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview with the Lab Manager the laboratory failed to perform a monthly QA (quality assurance) checklist per their policy for 2 out of 2 (2020-2022) years reviewed. Findings Included: Review of the policy and procedure manual (last signed as reviewed by the Laboratory Director on 12/21/2018) stated that the laboratory would complete a monthly QA checklist. No QA checklists had been completed in 2020, 2021, and 2022. On 08/16/2022 at 3:30 PM the Lab Manager confirmed that the QA checklist had not been completed in 2020, 2021, or 2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at St. Petersburg Dermatology on 05/06/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with the Histotech, the laboratory failed to perform preventative maintenance on the cryostat used in the Histopathology laboratory since the date of the last on-site survey, 12/04/18. Findings included: Record review of the laboratory's "Cryostat Maintenance" procedure revealed that "preventative maintenance and grounding checks are done and documented annually." Record review of the laboratory's "Cryostat" form revealed that the preventative maintenance had not been documented since 12/04/2018. Interview on 05/06/20 at 10: 05 AM with the Histotech confirmed that the preventative maintenance had not been performed on the cryostat, but she had made a call to schedule the preventative maintenance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the Laboratory Director failed to sign the procedure manual for approval before testing began in November 2018. Findings Included: Review of the policy and procedure manual revealed that it had not been signed by the Laboratory Director before beginning testing in November 2018. Interview on 12/04/18 at 1:30 PM with the Office Manager confirmed that the procedure manual had not been signed before testing commenced in November 2018. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory director did not ensure that there was documentation to indicate that two out of two testing personnel (#B and #C) had laboratory training to perform the mycology, parasitology, and histology testing since the laboratory began testing. Findings Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- included: Review of testing personnel records for Testing Personnel #B revealed no training records were present for histology. A review of the personnel records for Testing Personnel #C revealed no training records for mycology and parasitology testing. Interview on 12/04/2018 at 01:45 PM with the Office Manager confirmed the lack of training records for Testing Personnel #B and #C. -- 2 of 2 --